FDA-Device2025-07-09Class II
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Geneoscopy, Inc.
Hazard
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Sold states
US Nationwide distribution in the state of Missouri.
Affected count
10 units
Manufactured in
2220 Welsch Industrial Ct, Saint Louis, MO, United States
Products
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2025Don't want to check this manually?
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